SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS pio oo — PAGE1OF 48
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30
2 CONTRACT NO. 3. AWARDEFFECTIVEDATE | 4. ORDER NUMBER 5 SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE
W58P052200001 17-Nov-2021
INFORMATION CALL:
9. ISSUED BY 10. THIS ACQUISITION IS C emnmesen or | | SET ASIDE: % FOR:
0 OMEN-OWNED SMALL BUSINESS (WOSB)
ACC-APG - COVID RESPONSE - W58P05
6472 INTEGRITY COURT (BUILDING 4401)
ABERDEEN PROVING GROUND MD 21005-3013
ELIGIBLE UNDER THE WOMEN-OWNED
[_]swaue BUSINESS
SMALL BUSINESS PROGRAM
HUBZONE SMALL NAICS:
BUSINESS [_Jeowoss 325412
SERVICE-DISABLED
[] VETERAN-OWNED [Jew SIZE STANDARD:
SMALL BUSINESS 1,250
12. DISCOUNT TERMS
Net 30 Days
. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
. DELIVER TO
13b. RATING
14, METHOD OF SOLICITATION
[] 13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15 CFR 700)
16. ADMINISTERED BY
DCMA GARDEN CITY
207 NEW YORK AVENUE
STATEN ISLAND NY 10305-5013
SEE SCHEDULE
FACILITY
CODE
17a. CONTRACTOR/
OFFEROR
PFIZER INC.
PFIZER
235 E 42ND ST
NEW YORK NY 10017-5703
TELEPHONE NO.
[] 17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK
SUCH ADDRESS IN OFFER BELOW IS CHECKED | SEE ADDENDUM
19. 20. 21. 22. 23. 24.
ITEM NO. SCHEDULE OF SUPPLIES/ SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
25. ACCOUNTING AND APPROPRIATION DATA 26, TOTAL AWARD AMOUNT (For Govt. Use Only)
CODE 18a. PAYMENT WILL BE MADE BY CODE
HQ0337
DFAS-COLUMBUS CENTER
NORTH ENTITLEMENT OPERATIONS
P O BOX 182266
COLUMBUS OH 43218-2266
See Schedule
| SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3, 52.212-5 ARE ATTACHED. ADDENDA [pre [ = NOT ATTACHED
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA [x]are [_Jare NOT ATTACHED
29. AWARD OF CONTRACT: REF
OFFER DATED . YOUR OFFER ON SOLICITATION
(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE
SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 1
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY
ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.
Oa. SKSNA TURE OF OFFEROR/CONTRACTOR 31a.UNI
Ob.
30c. DATE SIGNED =| 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT)
31c. DATE SIGNED
(TY
2)-14-
2021-11-17 17NOV2021
EMAIL:
AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 1449 (REV. 2/2012)
PREVIOUS EDITION IS NOT USABLE Prescribed by GSA — FAR (48 CFR) 53.212
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS PAGE 2 OF 48
(CONTINUED)
19. 20. 21.
ITEM NO. SCHEDULE OF SUPPLIES/ SERVICES QUANTITY
SEE SCHEDULE
23. 24.
UNIT PRICE AMOUNT
22.
UNIT
[] RECEIVED [SINSeeerEe []
ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32b. SIGNATURE OF AUTHORIZED GOVERNMENT 32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT
REPRESENTATIVE REPRESENTATIVE
32a. QUANTITY IN COLUMN 21 HAS BEEN
32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE
33. SHIP NUMBER 34. VOUCHER NUMBER 35. AMOUNT VERIFIED 36. PAY MENT 37. CHECK NUMBER
CORRECT FOR
[[ParTiac| [FINAL] [J COMPLETE [ PARTIAL [] FINAL
38. S/R ACCOUNT NUMBER 1]39. S/R VOUCHER NUMBER |40. PAID BY
41a. | CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT | 42a. RECEIVED BY (Print)
41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE
42b. RECEIVED AT (Location)
42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS
AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 1449 (REV. 2/2012) BACK
PREVIOUS EDITION IS NOT USABLE Prescribed by GSA — FAR (48 CFR) 53.212
W58P0522C0001
Page 3 of 48
Section SF 1449 - CONTINUATION SHEET
EXECUTIVE SUMMARY
1. Background: In December of 2019, an outbreak of COVID-19 was reported in Wuhan City, Hubei Province,
China. The World Health Organization (WHO) states that COVID-19 is the infectious disease caused by the most
recently discovered coronavirus. The WHO declared the global COVID-19 outbreak a pandemic on 11 March 2020,
stating it is a “public health crisis.” On 31 January 2020, the U.S. Department of Health and Human Services (HHS)
Secretary declared a public health emergency (PHE) for the U.S. to aid the nation’s health care community in
responding to COVID-19. On 13 March 2020, the President of the United States of America declared COVID-19 an
emergency IAW 42 U.S.C. 5122 (the Robert T. Stafford Disaster Relief and Emergency Assistance Act) which
allows for Special Emergency Procurement Authority IAW 41 U.S.C.1903. On 18 March 2020, the President
invoked this authority in accordance with the Defense Production Act and later authorized the Operation Warp
Speed (OWS) Mission (now referred to as “Countermeasures Acceleration Group” (CAG)).
Under the President’s CAG Mission, Joint Program Executive Office for Chemical, Biological, Radiological and
Nuclear Defense (JPEO-CBRND), HHS, and Biomedical Advanced Research and Development Authority
(BARDA) are leading a whole of nation effort with the primary goal to execute and maintain a well-defined
portfolio of COVID-19 medical countermeasure candidates to maximize the probability of having safe and effective
diagnostics, therapeutics and vaccines, as fast as possible, for mass distribution.
In an effort to obtain innovative therapeutics for the treatment of COVID-19, the Government posted Medical
Countermeasures (MCM) Commercial Solutions Opening (CSO), Solicitation Number W911QY-20-S-C001, Area
of Interest (AoI) number A005 for an Oral Antiviral Therapeutic Treatment on the Government Point of Entry
website, SAM. gov. on 25 June 2021. Pfizer Incorporated responded to this CSO with their Oral Protease Inhibitor
drug PF-07321332 for the treatment of SARS-CoV-2. After review, the treatment was accepted by the Government.
Therefore, in furtherance of the United States Government’s goal, the Government will procure 10M treatment
courses of Pfizer’s oral antiviral therapeutic treatment.
2. This action has a Firm Fixed Price value of $5,295,000,000.00 At this time, CLIN 0001 is funded in the amount
of $5,295,000,000.00.
3. The Representations and Certifications made by Pfizer in the System for Award Management (SAM) are hereby
incorporated into this contract by reference.
4. The Pfizer Small Business Subcontracting Plan, effective January 1, 2021 to December 31, 2021, is hereby
incorporated into the contract (see Attachment 0001)
ITEM NO
0001
ITEM NO
000101
W58P0522C0001
Page 4 of 48
SUPPLIES/SERVICES UANTITY UNIT UNIT PRICE AMOUNT
a
Oral Protease Inhibitor PF-07321332
FFP
The contractor shall produce, store, and distribute 10,000,000 five (5) day
treatment courses of the oral protease inhibitor compound (oral antiviral treatment),
PF-07321332 IAW the Statement of Work (SOW), Product Release Schedule &
Delivery Information (Section G) and CDRLs (Exhibit A) on this contract. A unit
is defined as one full five (5) day treatment course.
The Contractor shall distribute the product as directed by the U.S. Government
(USG) with the contractor insuring against any supply loss from time of title
transfer at origin through to end destination (located within the United States,
including its territories and possessions) with replacement product transferred to
the USG. Transfer of product to USG and distribution will not occur unless, on the
date of transfer, there is an approved New Drug Application or active Emergency
Use Authorization for the product authorizing use of the drug to treat COVID-19 as
described in the SOW.
FOB: Destination
PSC CD: 6505
NET AMT ea
SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
$0.00
FFP
PURCHASE REQUEST NUMBER: 0011720874
NET AMT $0.00
ACRN AA ee
CIN: GFEBS001172087400001
ITEM NO
000102
ITEM NO
000103
ITEM NO
000104
SUPPLIES/SERVICES QUANTITY UNIT
FFP
PURCHASE REQUEST NUMBER: 0011720874
ACRN AB
CIN: GFEBS001172087400002
SUPPLIES/SERVICES QUANTITY UNIT
FFP
PURCHASE REQUEST NUMBER: 0011720874
ACRN AC
CIN: GFEBS001172087400003
SUPPLIES/SERVICES QUANTITY UNIT
FFP
PURCHASE REQUEST NUMBER: 0011720874
ACRN AD
CIN: GFEBS001172087400004
UNIT PRICE
NET AMT
UNIT PRICE
NET AMT
UNIT PRICE
NET AMT
W58P0522C0001
Page 5 of 48
AMOUNT
$0.00
$0.00
AMOUNT
$0.00
$0.00
AMOUNT
$0.00
$0.00
ITEM NO
000105
ITEM NO
000106
SUPPLIES/SERVICES QUANTITY UNIT
FFP
PURCHASE REQUEST NUMBER: 0011720874
ACRN AE
CIN: GFEBS001172087400005
SUPPLIES/SERVICES QUANTITY UNIT
FFP
PURCHASE REQUEST NUMBER: 0011720874
ACRN AF
CIN: GFEBS001172087400006
UNIT PRICE
NET AMT
UNIT PRICE
NET AMT
W58P0522C0001
Page 6 of 48
AMOUNT
$0.00
$0.00
AMOUNT
$0.00
$0.00
ITEM NO
000107
ITEM NO
000108
ITEM NO
000109
SUPPLIES/SERVICES QUANTITY UNIT
FFP
PURCHASE REQUEST NUMBER: 0011720874
ACRN AG
CIN: GFEBS001172087400007
SUPPLIES/SERVICES QUANTITY UNIT
FFP
PURCHASE REQUEST NUMBER: 0011720874
ACRN AH
CIN: GFEBS001172087400008
SUPPLIES/SERVICES QUANTITY UNIT
FFP
PURCHASE REQUEST NUMBER: 0011720874
ACRN AJ
CIN: GFEBS001172087400009
UNIT PRICE
NET AMT
UNIT PRICE
NET AMT
UNIT PRICE
NET AMT
W58P0522C0001
Page 7 of 48
AMOUNT
$0.00
$0.00
AMOUNT
$0.00
$0.00
AMOUNT
$0.00
$0.00
W58P0522C0001
Page 8 of 48
ITEM NO — SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
0002
1 Job NSP
Technical Data/Deliverables
FFP
The contractor shall deliver Technical Data IAW Contract Data Requirements List
(CDRL) IAW deliverables, Exhibit A
FOB: Origin (Shipping Point)
PROJECT: COVID-19 CAG
PSC CD: 6505
NET AMT
STATEMENT OF WORK
Proprietary and Confidential Business Information Exempt from Disclosure Under FOIA
Exemption Four
STATEMENT OF WORK
ORAL ANTIVIRAL THERAPEUTIC TREATMENT
C.1.1. GENERAL
C.1.2. Objective
The Joint Program Executive Office - Chemical Biological Radiological Nuclear Defense
(JPEO-CBRN) in coordination with the Biomedical Advanced Research and Development
Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and
Response (ASPR) at the U.S. Department of Health and Human Services (HHS) seeks to
acquire treatment courses of critical therapeutics for the COVID-19 response. The JPEO will
coordinate the activities as awarded under these contracts.
C.1.3. Background
In December 2019, a novel (new) coronavirus known as SARS-CoV-2 (“the virus”) was first
detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the
coronavirus disease COVID-19 that has now spread globally. The Secretary of HHS declared a
public health emergency on January 31, 2020, under section 319 of the Public Health Service
Act (42 U.S.C. § 247d), in response to COVID-19. On March 1, 2020, the President of the
United States, pursuant to sections 01 and 301 of the National Emergencies Act (50 U.S.C. §
1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42
W58P0522C0001
Page 9 of 48
U.S.C. § 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a
national emergency.
Under the U.S. Government’s (USG) COVID-19 Response mission, HHS is leading a whole of
nation effort with the primary goal to execute on a well-defined portfolio of COVID-19 medical
countermeasure (MCM) candidates to maximize availability of safe and effective vaccines,
therapeutics and diagnostics as fast as possible for mass distribution. As such, BARDA has a
specific need to procure orally administered, direct-acting antiviral therapeutic treatment.
C.1.4. Scope of Work
The USG seeks delivery of an orally administered, direct-acting antiviral therapeutic
authorized or approved by the Food and Drug Administration (FDA) to treat high risk
outpatients with a reduction of hospitalization and/or mortality endpoint, all outpatients with a
symptom alleviation endpoint, and/or post- and pre-exposed populations demonstrating a
reduction in symptomatic COVID-19. The therapeutic shall have completed all testing and
manufacturing to support delivery of the established quantities, within the timelines established
under this contract.
Alternative endpoints may be considered if they are accepted by the FDA. Emergency Use
Authorization (EUA) shall be obtained no later than end of Quarter 1 of Calendar Year 2022
(Q1 CY2022) and/or New Drug Application (NDA) approval no later than end of Q3 CY2022
subject to technical, clinical and manufacturing success and FDA authorization/approval.
C.2. TASKS
C.2.1 Task 1 - Product Development Source Material and Manufacturing Plan. The Contractor
shall provide a Product Development Source Material and Manufacturing Plan within 30 days
of award to fulfill the USG order. The Manufacturing Plan shall include all materials required
for drug substance/active pharmaceutical ingredient manufacturing and finished drug
product(s), an acquisition plan for acquiring necessary materials, all key subcontractors and
manufacturing sites, and a detailed schedule for providing the final product to the USG. If
multiple indications are under consideration, a timeline and quantity of drug for each indication
should be provided.
C.2.2 Task 2 — Manufacture. The Contractor shall manufacture the therapeutic product(s)
using an established manufacturing process for active pharmaceutical ingredient, bulk drug
product and pack/labelled final drug product, with a ramp-up capacity plan that provides
enough doses to meet the desired number of treatment courses. The Contractor shall
manufacture according to Current Good Manufacturing Practice (CGMP) commensurate with
the conditions submitted and authorized by the FDA through the Emergency Use Authorization
application.
C.2.3 Task 3 — Storage. The Contractor shall store the packaged drug product under cGMP
conditions until EUA and/or FDA approval. Following EUA or FDA approval, the product
shall be stored for a period of up to six months after initial acceptance by the USG. Timing
for this acceptance will be as outlined in the contract. The Contractor shall not be obligated to
rotate stock at any time during the six-month storage period. The USG acknowledges and
W58P0522C0001
Page 10 of 48
agrees that for product stored by the Contractor at USG’s request, USG shall not be entitled to
a refund for product based on actual shelf life remaining upon delivery to the end destination.
C.2.4 Task 4 — Distribution. The Contractor, through its distributor (or distributors as the
USG may permit) shall distribute product quantities to locations as directed by the USG
consistent with the terms of this SOW. Contractor shall use a single distribution company to
distribute product with the Contractor insuring against any supply loss from time of title
transfer at origin through to end destination, i.e. pharmacies, located within the United States
(including its territories and possessions). During performance of this contract, the Contractor
may request Government approval to add additional distribution companies. Said approval
shall be at the sole discretion of the Government. Transfer of product to USG and distribution
shall not occur unless, on the date of transfer, there is an active EUA or FDA approval for the
product authorizing use of the drug to treat COVID-19 for the agreed upon indication.
The single distributor must meet the following requirements as specified and agreed upon in
the Distribution Plan and Memorandum of Understanding:
a. Product shall be shipped within 24 hours from initial receipt of order.
b. Shipments shall be monitored for the duration of transit and all information regarding
shipments and orders shall be provided to the USG.
Provide notification to USG in the event of a delay of shipment.
d. Provide package recovery when shipments are required to be returned due to
unavailability of delivery.
e. The distributor must be able to interface with the USG Ordering Portal, Health Partner
Ordering Portal (HPOP).
fo)
The Contractor shall provide the following data deliverables in accordance with the CDRLs
outlined in Attachment I, Antiviral Deliverables Table:
CDRL A007 Supply Chain and Distribution Tracking
CDRL A008 Distribution Plan
CDRL A009 Distribution Memorandum of Understanding
C.2.5 Task 5 - Material Transfer Agreement (MTA).
Within 10 days of USG providing Contractor with a draft National Institute of Allergy and
Infectious Diseases (NIAID) Non-Clinical Evaluation Agreement between Contractor and the
USG (the “MTA”), which is substantially similar to the draft previously provided to
Contractor, the Parties will execute the MTA, provided that both Parties have engaged in a
good faith negotiation, to include the following material terms:
(i) At the USG’s request, the Parties would execute no more than ten (10) HHS Division of
Microbiology and Infectious Diseases (DMID) Service Request Forms for:
(a) the evaluation of PF-07321332 as a single agent in a SARS-CoV2 live virus variant
assay (each an “In Vitro SRF’), wherein the assay will be performed at one or more
currently authorized USG supported test sites, will include remdesivir as a positive
control as well as other blinded test articles selected from clinical candidates of
interest to the USG and related analogs thereof, and, if Vero cells (or other cells with
strong efflux pumps) are used, the experiment(s) will be conducted in the presence of
an efflux inhibitor provided by Contractor, provided that (a) if the test site differs
W58P0522C0001
Page 11 of 48
from NIAID-IRF and the assay protocol no. VR-05-04 entitled Single Drug Screen
Assay — 384 well plate which was provided to Contractor, prior to executing the In
Vitro SRF, USG would provide Contractor with at least thirty (30) days to provide
input on the design of the live virus variant testing assay and to, at Contractor’s sole
discretion and pursuant to Sections 6.3, 6.4, and 6.6 of the MTA, allow Contractor to
negotiate with the USG supported test site(s) with regards to a license to any
Contractor Subject Inventions (as defined in the MTA) which are not Class 1 Subject
Inventions (as defined in the MTA) and (b) each In Vitro SRF would not obligate
Contractor to provide more than 10 mg powder (or an equivalent solubilized stock) of
PF-07321332; and/or
(b) for the evaluation of PF-07321332 as a single agent in a mouse model against SARS-
CoV-2 variants that are capable of establishing infection in wildtype mice (“In Vivo
SRF”), wherein the assay would be performed at one or more currently authorized
USG-supported test sites, and will use an appropriate positive control as well as other
blinded test articles selected from clinical candidates of interest to the USG and
related analogs thereof, provided that (a) prior to executing the In Vivo SRF, (1) USG
would share the details of the planned in vivo studies with Contractor and (2) USG
would provide Contractor with at least thirty (30) days to provide input on the study
design and to, at Contractor’s sole discretion and pursuant to Sections 6.3, 6.4 and 6.6
of the MTA, allow Contractor to negotiate with the USG supported test site(s) with
regards to a license to any Contractor Subject Inventions which are not Class |
Subject Inventions, and (b) the In Vivo SRF would not obligate Contractor to provide
more than 10 g of PF-07321332.
(11) The USG shall agree, and shall cause its Contractors to agree, to comply with standard
academic practice regarding authorship of scientific publications and recognition of
contribution of other parties in any publication of results involving unblinded products
arising from the MTA, including International Committee of Medical Journal Editors
standards regarding authorship and contributions.
(111) Absent Contractor’s advance written consent, which consent would be in Contractor’s
sole discretion, the USG shall agree, and shall cause each Contractor to agree, it will not
use PF-07321332 as a control in any assays, use PF-07321332 in any drug development-
related activities, nor test PF-07321332 in combination with other therapeutics or
potential therapeutics.
To the extent there is a conflict between the terms of this section C.2.5 and the MTA, the terms
of the MTA shall govern work to be performed under the MTA.
C.2.6. Task 6 - Informational Material. To the extent consistent with the terms of any EUA as
well as applicable legal, regulatory or compliance requirements or guidance, including but not
limited to requirements or guidance under the Food, Drug and Cosmetic Act, the Contractor
shall develop learning material to assist in administration and increase uptake of their drug to
the public including but not limited to pamphlets, infomercials, websites, etc. Contractor will
make a reasonable effort to share core draft educational materials with the USG (BARDA)
W58P0522C0001
Page 12 of 48
during the creation process. The USG may provide comments on Educational Materials to
Contractor within 3 business days for Contractor’s consideration.
C.2.7 Task 7 - Program Management Activities. The Contractor shall manufacture in
compliance with FDA cGMP commensurate with the conditions submitted and
authorized by FDA through the Emergency Use Authorization application. The Contractor
shall be responsible for management of all activities, including but not limited to managing
subcontractors to meet the goals of the contract, holding routine meetings with USG, and
completion of meeting minutes.
C.3.0 DELIVERABLES
C.3.1. The Contractor shall provide the information deliverables to the USG, in accordance with
theContract Data Requirement List (CDRL), Section J, Exhibit A.
INSPECTION AND ACCEPTANCE TERMS
Supplies/services will be inspected/accepted at:
CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY
0001 Origin Government Origin Government
000101 N/A N/A N/A N/A
000102 N/A N/A N/A N/A
000103 N/A N/A N/A N/A
000104 N/A N/A N/A N/A
000105 N/A N/A N/A N/A
000106 N/A N/A N/A N/A
000107 N/A N/A N/A N/A
000108 N/A N/A N/A N/A
000109 N/A N/A N/A N/A
0002 ~=— Origin Government Origin Government
CONTRACT ADMINISTRATION
GOVERNMENT CONTRACT ADMINISTRATION
In no event shall any understanding or agreement, contract modification, change order, or other matter in
deviation from the terms of this contract between the Contractor and a person other than the Contracting
Officer be effective or binding upon the Government. All such actions must be formalized by a proper
contractual document executed by the Contracting Officer.
GA po
W58P0522C0001
Page 13 of 48
ACC Joint COVID-19 Response Division
G.2 GOVERNMENT TECHNICAL POINT OF CONTACT
G.3 CONTRACTOR’S CONTRACT ADMINISTRATION
G.4 PLACES OF PERFORMANCE
Pfizer Headquarters
235 East 42nd Street
New York, NY 10038
G.5 NOTIFICATION OF REVISIONS AND CHANGE
Notification of revision or changes to names or email addresses will be provided by official
correspondence from the PCO or office of the PCO in lieu of a contract modification. This does not apply
to any such revisions or changes in the event this contract includes a key personnel clause.
PRODUCT RELEASE SCHEDULE
Contractor shall make quantities of the Final Drug Product that are suitable for release available for
Government inspection in accordance with the table below:
Product Release Schedule
[ [ee [ee] ree] mar | Aor | may | ne | ml | Aw [Sep [Tol |
[unites [50.000 | 300,000 | 150,000 | 200,000 | sooc00 | 600,000 [ 75,000 | 1.20,000 | 300,000 | 3,250,000 | 070,000 |
*As used herein, a "unit" is defined as one treatment course.
All treatment courses must have an active FDA authorization or approval at time of delivery. If the FDA
has not yet authorized or approved the product at the time of scheduled product release in any month
per the table above, the Contractor shall retain the product until the FDA authorizes or approves the
product, and Contractor shall then release all doses due to the Government in the month in which the
FDA authorization or approval is granted. Delayed release in any particular month shall not result in an
adjustment to the remainder of the release schedule. The Contractor will make its best effort to accelerate
the above release schedule, and accelerated release deliveries will be at no additional cost to the
Government.
W58P0522C0001
Page 14 of 48
DELIVERY INFORMATION
CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /
CAGE
0001 31-DEC-2021 50,000 N/A
FOB: Destination
0001 31-JAN-2022 100,000 N/A
FOB: Destination
0001 28-FEB-2022 150,000 N/A
FOB: Destination
0001 31-MAR-2022 400,000 N/A
FOB: Destination
0001 30-APR-2022 500,000 N/A
FOB: Destination
0001 31-MAY-2022 600,000 N/A
FOB: Destination
0001 30-JUN-2022 750,000 N/A
FOB: Destination
0001 31-JUL-2022 1,200,000 N/A
FOB: Destination
0001 31-AUG-2022 3,000,000 N/A
FOB: Destination
0001 30-SEP-2022 3,250,000 N/A
FOB: Destination
000101 N/A N/A N/A N/A
000102 N/A N/A N/A N/A
000103 N/A N/A N/A N/A
000104 N/A N/A N/A N/A
000105 N/A N/A N/A N/A
000106 N/A N/A N/A N/A
000107 N/A N/A N/A N/A
000108 N/A N/A N/A N/A
W58P0522C0001
Page 15 of 48
000109 N/A N/A N/A N/A
0002. N/A N/A N/A N/A
ACCOUNTING AND APPROPRIATION DATA
AA: 0212021202220400000664643260
COST CODE: ASXAH
AMOUNT ii
AB: 0212021202220400000664643260
COST CODE: ASXAH
AMOUNT iS
AC: 0212021202220400000664643260
COST CODE: ASXAH
AMOUNT:
AD: 0212021202220400000664643260
COST CODE: ASXAH
AMOUNT:
AE: 0212021202220400000664643260
COST CODE: ASXAH
AMOUNT:
AF: 0212021202220400000664643260
COST CODE: ASXAH
AMOUNT:
AG: 0212021202220400000664643260
COST CODE: ASXAH
AMOUNT
AH: 0212021202220400000664643260
COST CODE: ASXAH
AMOUNT:
AJ- 0212021202220400000664643260
COST CODE: ASXAH
$.0074658.7.4.4.1
$.0074658.7.4.4.3
$.0074658.7.4.4.4
$.0074658.7.4.4.5
$.0074658.7.4.4.6
$.0074658.7.4.4.7
$.0074658.7.4.4.8
$.0074658.7.4.4.9
$.0074658.7.4.4.10
AMOUNT
ACRN_~ CLIN/SLIN CIN
AA 000101 GFEBS001172087400001
AB 000102 GFEBS001172087400002
AC 000103 GFEBS001172087400003
AD 000104 GFEBS001172087400004
AE 000105 GFEBS001172087400005
AF 000106 GFEBS001172087400006
AG 000107 GFEBS001172087400007
AH 000108 GFEBS001172087400008
AJ 000109 GFEBS001172087400009
CLAUSES INCORPORATED BY REFERENCE
6100.0152021001
6100.0152021001
6100.0152021001
6100.0152021001
6100.0152021001
6100.0152021001
6100.0152021001
6100.0152021001
6100.0152021001
AMOUNT
52.203-3
52.203-6 Alt I
52.203-12
52.204-4
52.204-13
52.204-18
52.204-19
52.204-24
52.212-4
52.219-9
52.222-50
52.232-33
52.232-40
52.233-1
52.242-13
52.245-1
52.245-9
52.246-2
52.246-16
52.247-34
252.203-7000
252.203-7003
252.204-7003
252.204-7006
252.204-7012
252.204-7015
252.205-7000
252.209-7004
252.211-7007
252.225-7012
252.225-7048
252.227-7015
252.227-7037
252.232-7003
252.232-7010
252.232-7017
252.243-7002
252.244-7000
252.245-7001
Gratuities
Restrictions On Subcontractor Sales To The Government
(JUN 2020) -- Alternate I
Limitation On Payments To Influence Certain Federal
Transactions
Printed or Copied Double-Sided on Postconsumer Fiber
Content Paper
System for Award Management Maintenance
Commercial and Government Entity Code Maintenance
Incorporation by Reference of Representations and
Certifications.
Representation Regarding Certain Telecommunications and
Video Surveillance Services or Equipment.
Contract Terms and Conditions--Commercial Items
Small Business Subcontracting Plan
Combating Trafficking in Persons
Payment by Electronic Funds Transfer--System for Award
Management
Providing Accelerated Payments to Small Business
Subcontractors
Disputes
Bankruptcy
Government Property
Use And Charges
Inspection Of Supplies--Fixed Price
Responsibility For Supplies
F.O.B. Destination
Requirements Relating to Compensation of Former DoD
Officials
Agency Office of the Inspector General
Control Of Government Personnel Work Product
Billing Instructions
Safeguarding Covered Defense Information and Cyber
Incident Reporting
APR 1984
OCT 1995
JUN 2020
MAY 2011
OCT 2018
AUG 2020
DEC 2014
OCT 2020
OCT 2018
JUN 2020
OCT 2020
OCT 2018
DEC 2013
MAY 2014
JUL 1995
SEP 2021
APR 2012
AUG 1996
APR 1984
NOV 1991
SEP 2011
AUG 2019
APR 1992
OCT 2005
DEC 2019
Notice of Authorized Disclosure of Information for Litigation MAY 2016
Support
Provision Of Information To Cooperative Agreement Holders DEC 1991
Subcontracting With Firms That Are Owned or Controlled By MAY 2019
The Government of a Country that is a State Sponsor of
Terrorism
Reporting of Government-Furnished Property
Preference For Certain Domestic Commodities
Export-Controlled Items
Technical Data--Commercial Items
Validation of Restrictive Markings on Technical Data
Electronic Submission of Payment Requests and Receiving
Reports
Levies on Contract Payments
Accelerating Payments to Small Business Subcontractors--
Prohibition on Fees and Consideration
Requests for Equitable Adjustment
Subcontracts for Commercial Items
Tagging, Labeling, and Marking of Government-Furnished
Property
AUG 2012
DEC 2017
JUN 2013
FEB 2014
SEP 2016
DEC 2018
DEC 2006
APR 2020
DEC 2012
JAN 2021
APR 2012
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252.245-7002 Reporting Loss of Government Property JAN 2021
252.245-7003 Contractor Property Management System Administration APR 2012
252.245-7004 Reporting, Reutilization, and Disposal DEC 2017
252.247-7023 Transportation of Supplies by Sea FEB 2019
WAWF Army Electronic Invoicing FEB 2006
CLAUSES INCORPORATED BY FULL TEXT
52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN TELECOMMUNICATIONS AND VIDEO
SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2020)
(a) Definitions. As used in this clause--
Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks at
the edge of the network (e.g., connecting cell phones/towers to the core telephone network). Backhaul can be
wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).
Covered foreign country means The People's Republic of China.
Covered telecommunications equipment or services means--
(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any
subsidiary or affiliate of such entities);
(2) For the purpose of public safety, security of Government facilities, physical security surveillance of critical
infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced
by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology
Company (or any subsidiary or affiliate of such entities);
(3) Telecommunications or video surveillance services provided by such entities or using such equipment; or
(4) Telecommunications or video surveillance equipment or services produced or provided by an entity that the
Secretary of Defense, in consultation with the Director of National Intelligence or the Director of the Federal Bureau
of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise connected to, the
government of a covered foreign country.
Critical technology means--
(1) Defense articles or defense services included on the United States Munitions List set forth in the International
Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;
(2) Items included on the Commerce Control List set forth in Supplement No. | to part 774 of the Export
Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and
controlled--
(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological
weapons proliferation, nuclear nonproliferation, or missile technology; or
(ii) For reasons relating to regional stability or surreptitious listening;
(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology
covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy
activities);
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(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating
to export and import of nuclear equipment and material);
(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such
Code, or part 73 of title 42 of such Code; or
(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act
of 2018 (50 U.S.C. 4817).
Interconnection arrangements means arrangements governing the physical connection of two or more networks to
allow the use of another's network to hand off traffic where it is ultimately delivered (e.g., connection of a customer
of telephone provider A to a customer of telephone company B) or sharing data and other information resources.
Reasonable inquiry means an inquiry designed to uncover any information in the entity's possession about the
identity of the producer or provider of covered telecommunications equipment or services used by the entity that
excludes the need to include an internal or third-party audit.
Roaming means cellular communications services (e.g., voice, video, data) received from a visited network when
unable to connect to the facilities of the home network either because signal coverage is too weak or because traffic
is too high.
Substantial or essential component means any component necessary for the proper function or performance of a
piece of equipment, system, or service.
(b) Prohibition.
(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.
115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or
extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered
telecommunications equipment or services as a substantial or essential component of any system, or as critical
technology as part of any system. The Contractor is prohibited from providing to the Government any equipment,
system, or service that uses covered telecommunications equipment or services as a substantial or essential
component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of this
clause applies or the covered telecommunication equipment or services are covered by a waiver described in FAR
4.2104.
(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.
115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract, or
extending or renewing a contract, with an entity that uses any equipment, system, or service that uses covered
telecommunications equipment or services as a substantial or essential component of any system, or as critical
technology as part of any system, unless an exception at paragraph (c) of this clause applies or the covered
telecommunication equipment or services are covered by a waiver described in FAR 4.2104. This prohibition
applies to the use of covered telecommunications equipment or services, regardless of whether that use is in
performance of work under a Federal contract.
(c) Exceptions. This clause does not prohibit contractors from providing--
(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection
arrangements; or
(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user
data or packets that such equipment transmits or otherwise handles.
(d) Reporting requirement.
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(1) In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or
essential component of any system, or as critical technology as part of any system, during contract performance, or
the Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor shall report the
information in paragraph (d)(2) of this clause to the Contracting Officer, unless elsewhere in this contract are
established procedures for reporting the information; in the case of the Department of Defense, the Contractor shall
report to the website at https://dibnet.dod.mil. For indefinite delivery contracts, the Contractor shall report to the
Contracting Officer for the indefinite delivery contract and the Contracting Officer(s) for any affected order or, in
the case of the Department of Defense, identify both the indefinite delivery contract and any affected orders in the
report provided at https://dibnet.dod mil.
(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause:
(i) Within one business day from the date of such identification or notification: The contract number; the order
number(s), if applicable; supplier name; supplier unique entity identifier (if known); supplier Commercial and
Government Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number,
manufacturer part number, or wholesaler number); item description; and any readily available information about
mitigation actions undertaken or recommended.
(ii) Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: Any further available
information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the
efforts it undertook to prevent use or submission of covered telecommunications equipment or services, and any
additional efforts that will be incorporated to prevent future use or submission of covered telecommunications
equipment or services.
(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e) and excluding
paragraph (b)(2), in all subcontracts and other contractual instruments, including subcontracts for the acquisition of
commercial items.
(End of clause)
52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR
EXECUTIVE ORDERS--COMMERCIAL ITEMS (JUL 2021)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are
incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to
acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)
(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by
Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or
Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).
(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
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(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19
U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has
indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders
applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)
X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (Oct 1995) (41
U.S.C. 4704 and 10 U.S.C. 2402).
X (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN
2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment
Act of 2009.)
X (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-
282) (31 U.S.C. 6101 note).
___ (5) [Reserved]
(6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div.
C).
(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub.
L. 111-117, section 743 of Div. C).
X (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended,
or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
X (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) (41
U.S.C. 2313).
(10) [Reserved]
(11)@) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).
(ii) Alternate I (MAR 2020) of 52.219-3.
(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020)
(if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).
_____ (ii) Alternate I (MAR 2020) of 52.219-4.
____ (13) [Reserved]
__(14)@)_ 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).
___ (ii) Alternate I (MAR 2020) of 52.219-6.
___ (15)(@i)_ 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).
____ (ii) Alternate I (MAR 2020) of 52.219-7.
(16) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)).
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___ (17)@) 52.219-9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).
___ (ii) Alternate I (NOV 2016) of 52.219-9.
___ (iii) Alternate II (NOV 2016) of 52.219-9.
___ (iv) Alternate III (JUN 2020) of 52.219-9.
___ (v) Alternate IV (JUN 2020) of 52.219-9.
____ (18) Gi) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(1)).
____ (ii) Alternate I (MAR 2020) of 52.219-13.
____ (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).
__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15
U.S.C. 657f).
X (22) (4) 52.219-28, Post Award Small Business Program Rerepresentation (NOV 2020) (15 U.S.C. 632(a)(2)).
(ii) Alternate I (MAR 2020) of 52.219-28.
(23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-
Owned Small Business (EDWOSB) Concerns (MAR 2020) (15 U.S.C. 637(m)).
(24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns
Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).
(25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(1)).
___ (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)).
X (27) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).
X (28) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126).
X (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
X (30)(i) 52.222-26, Equal Opportunity (SEPT 2016) (E.O. 11246).
____ (ii) Alternate I (FEB 1999) of 52.222-26.
X (31)(i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
____ (ii) Alternate I (JUL 2014) of 52.222-35.
X (32)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
____ (ii) Alternate I (JUL 2014) of 52.222-36.
X (33) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
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X (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O.
13496).
X (35)(1) 52.222-50, Combating Trafficking in Persons (OCT 2020) (22 U.S.C. chapter 78 and E.O. 13627).
(ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
X (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the
acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in
22.1803.)
(37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated Items (MAY
2008) (42 U.S.C. 6962(c)(3)(A)(i1)). (Not applicable to the acquisition of commercially available off-the-shelf
items.)
(11) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of
commercially available off-the-shelf items.)
(38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN
2016) (E.O. 13693).
(39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners
(JUN 2016) (E.O. 13693).
(40) (i) 52.223-13, Acquisition of EPEAT® Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and
13514).
_____ (ii) Alternate I (OCT 2015) of 52.223-13.
—____ (41)@) 52.223-14, Acquisition of EPEAT® Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).
____ (ii) Alternate I (JUN 2014) of 52.223-14.
___ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).
(43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s
13423 and 13514).
(ii) Alternate I (JUN 2014) of 52.223-16.
X (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O.
13513).
____ (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).
_ (46) 52.223-21, Foams (JUN 2016) (E.O. 13693).
—__ (47)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).
____ (ii) Alternate I (JAN 2017) of 52.224-3.
(48) 52.225-1, Buy American--Supplies (JAN 2021) (41 U.S.C. chapter 83).
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—____ (49) (a) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (JAN 2021) (41 U.S.C. chapter
83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77,
108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.
____ (ii) Alternate I (JAN 2021) of 52.225-3.
____ (iii) Alternate IT (JAN 2021) of 52.225-3.
___ (iv) Alternate III (JAN 2021) of 52.225-3.
___ (50) 52.225-5, Trade Agreements (OCT 2019) 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
X (51) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) (E.O.'s, proclamations, and statutes
administered by the Office of Foreign Assets Control of the Department of the Treasury).
(52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016)
(Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C. 5150
(54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (NOV 2007) (42 U.S.C.
5150).
(55) 52.229-12, Tax on Certain Foreign Procurements (FEB 2021).
(56) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 4505, 10
U.S.C. 2307(f)).
(57) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
X (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018) (31 U.S.C.
3332).
(59) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (JUL
2013) (31 U.S.C. 3332).
(60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).
(61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).
X (62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).
(63)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C.
55305 and 10 U.S.C. 2631).
(11) Alternate I (APR 2003) of 52.247-64.
(iii) Alternate II (FEB 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that
the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of
law or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)
(1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).
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(2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C.
chapter 67).
(3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (Multiple
Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (MAY
2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).
(5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment--Requirements (MAY 2014) (41 U.S.C. chapter 67).
(6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services--Requirements (MAY 2014) (41 U.S.C. chapter 67).
(7) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020) (E.O. 13658).
(8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph
(d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as
defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and
Records--Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall
have access to and right to examine any of the Contractor's directly pertinent records involving transactions related
to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other
evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any
shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If
this contract is completely or partially terminated, the records relating to the work terminated shall be made
available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes
clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available
until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data,
regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that
the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the
Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1)in a subcontract for
commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the
clause—
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(11) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)
(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.
113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(ii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by
Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
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(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or
Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts
that offer further subcontracting opportunities. If the subcontract (except subcontracts
to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract
award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug 2018), (41 U.S.C. chapter 67).
(xiil) (A) 52.222-50, Combating Trafficking in Persons (OCT 2020) (22 U.S.C. chapter 78 and E.O. 13627).
(B) Alternate I (March 2, 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for
Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)
(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services--Requirements (May 2014) (41 U.S.C. chapter 67)
(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020) (E.O. 13658).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section
862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (JUN 2020) (42 U.S.C. 1792). Flow
down required in accordance with paragraph (e) of FAR clause 52.226-6.
(xxil) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. 55305 and
10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.
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(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of
additional clauses necessary to satisfy its contractual obligations.
(End of clause)
52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (NOV 2020)
(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an
authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.
(b) The use in this solicitation or contract of any Defense Federal Acquisition Regulation Supplement (48 CFR
Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the
regulation.
(End of clause)
252.204-7018 PROHIBITION ON THE ACQUISITION OF COVERED DEFENSE TELECOMMUNICATIONS
EQUIPMENT OR SERVICES (JAN 2021)
(a) Definitions. As used in this clause--
Covered defense telecommunications equipment or services means--
(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation, or any
subsidiary or affiliate of such entities;
(2) Telecommunications services provided by such entities or using such equipment; or
(3) Telecommunications equipment or services produced or provided by an entity that the Secretary of Defense
reasonably believes to be an entity owned or controlled by, or otherwise connected to, the government of a covered
foreign country.
Covered foreign country means--
(1) The People's Republic of China; or
(2) The Russian Federation.
Covered missions means--
(1) The nuclear deterrence mission of DoD, including with respect to nuclear command, control, and
communications, integrated tactical warning and attack assessment, and continuity of Government; or
(2) The homeland defense mission of DoD, including with respect to ballistic missile defense.
Critical technology means--
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(1) Defense articles or defense services included on the United States Munitions List set forth in the International
Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal Regulations;
(2) Items included on the Commerce Control List set forth in Supplement No. | to part 774 of the Export
Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations, and
controlled--
(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical and biological
weapons proliferation, nuclear nonproliferation, or missile technology; or
(ii) For reasons relating to regional stability or surreptitious listening;
(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, and technology
covered by part 810 of title 10, Code of Federal Regulations (relating to assistance to foreign atomic energy
activities);
(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations (relating
to export and import of nuclear equipment and material);
(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9 of such
Code, or part 73 of title 42 of such Code; or
(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control Reform Act
of 2018 (50 U.S.C. 4817).
Substantial or essential component means any component necessary for the proper function or performance of a
piece of equipment, system, or service.
(b) Prohibition. In accordance with section 1656 of the National Defense Authorization Act for Fiscal Year 2018
(Pub. L. 115-91), the contractor shall not provide to the Government any equipment, system, or service to carry out
covered missions that uses covered defense telecommunications equipment or services as a substantial or essential
component of any system, or as critical technology as part of any system, unless the covered defense
telecommunication equipment or services are covered by a waiver described in Defense Federal Acquisition
Regulation Supplement 204.2104.
(c) Procedures. The Contractor shall review the list of excluded parties in the System for Award Management
(SAM) at https://www.sam.gov for entities that are excluded when providing any equipment, system, or service, to
carry out covered missions, that uses covered defense telecommunications equipment or services as a substantial or
essential component of any system, or as critical technology as part of any system, unless a waiver is granted.
(d) Reporting.
(1) In the event the Contractor identifies covered defense telecommunications equipment or services used as a
substantial or essential component of any system, or as critical technology as part of any system, during contract
performance, the Contractor shall report at https://dibnet.dod.mil the information in paragraph (d)(2) of this clause.
(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause:
(i) Within 3 business days from the date of such identification or notification: The contract number; the order
number(s), if applicable; supplier name; brand; model number (original equipment manufacturer number,
manufacturer part number, or wholesaler number); item description; and any readily available information
about mitigation actions undertaken or recommended.
(ii) Within 30 business days of submitting the information in paragraph (d)(2)(i) of this clause: Any further available
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information about mitigation actions undertaken or recommended. In addition, the Contractor shall describe the
efforts it undertook to prevent use or submission of a covered defense telecommunications equipment or services,
and any additional efforts that will be incorporated to prevent future use or submission of covered
telecommunications equipment or services.
(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e), in all
subcontracts and other contractual instruments, including subcontracts for the acquisition of commercial items.
(End of clause)
252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)
(a) Definitions. As used in this clause—
“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit,
activity, or organization.
“Document type” means the type of payment request or receiving report available for creation in Wide Area
WorkFlow (WAWF).
“Local processing office (LPO)” is the office responsible for payment certification when payment certification is
done external to the entitlement system.
“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of
Payment Requests and Receiving Reports.
(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests
and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-
7003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Contractor shall—
(1) Have a designated electronic business point of contact in the System for Award Management at
https://(www.sam.gov; and
(2) Be registered to use WAWE at https://wawf.eb mil/ following the step-by-step procedures for self-registration
available at this web site.
(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training
Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be
accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb mil/.
(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data
Interchange, or File Transfer Protocol.
(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment
requests and receiving reports in WAWF for this contract or task or delivery order:
(1) Document type. The Contractor shall submit payment requests using the following document type(s): COMBO
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(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.
(ii) For fixed price line items—
(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting
Officer.
Invoice (Contractor Only)
(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the
requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the
Contracting Officer.
Invoice as 2-in-1
(iii) For customary progress payments based on costs incurred, submit a progress payment request.
(iv) For performance based payments, submit a performance based payment request.
(v) For commercial item financing, submit a commercial item financing request.
(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the
contract.
[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and
receiving report in one step.]
(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in
applicable fields in WAWF when creating payment requests and receiving reports in the system.
Routing Data Table*
Field Name in WAWF Data to be entered in WAWF
Pay Official DoDAAC HQ0337
Issue By DoDAAC WS58P05
Admin DoDAAC** W58P05
Inspect By DODAAC WS56XNH
Ship To Code WS56XNH
(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type
of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition
Regulation 52.216-7, Allowable Cost and Payment, as applicable.
(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.
(g) WAWF point of contact.
(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s
WAWF point of contact.
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(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
FOR REFERANCE:DFARS PGI 204.7108 Payment Instructions Table
https://www.acq.osd.mil/dpap/dars/pgi/pgi_htm/current/PGI204_71.htm#payment_instructions
(End of clause)
CAG SPECIAL CLAUSES (SEC. H)
TERMS AND CONDITIONS
SPECIAL CONTRACT REQUIREMENTS
H.1 Disclosure of Information:
Performance under this contract may require the Contractor to access non-public data and information proprietary to
a Government agency, another Government Contractor or of such nature that its dissemination or use other than as
specified in the work statement would be adverse to the interests of the Government or others. Neither the
Contractor, nor Contractor personnel, shall divulge nor release data nor information developed or obtained under
performance of this contract, except authorized by Government personnel or upon written approval of the
Contracting Officer which the Contracting Officer will provide in accordance with Countermeasures Acceleration
Group (CAG) or other Government policies and/or guidance. The Contractor shall not use, disclose, or reproduce
proprietary data that bears a restrictive legend, other than as specified in this contract, or any information at all
regarding this agency. The Contractor shall comply with all applicable Government requirements for protection of
non-public Government or third-party information. Unauthorized disclosure of nonpublic information is prohibited
by the Government’s rules. Unauthorized disclosure may result in termination of the contract, replacement of a
Contractor employee, or other appropriate redress.
Neither the Contractor nor the Contractor’s employees shall disclose or cause to be disseminated, any information
concerning the delivery timing or sites, which could result in, or increase the likelihood of, the possibility of a
breach of the activity’s security or interrupt the continuity of its operations. No information related to data obtained
under this contract relating to delivery timing or sites shall be released or publicized without the prior written
consent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no
such consent is required for the following activities: (1) to comply with any law, rule, regulation, court ruling or
similar order; (2) for submission to any government entity for submission to any securities exchange on which the
Contractor’s (or its parent corporation’s) securities may be listed for trading; or (3) provision to third parties
relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance,
financing and capital raising activities, or mergers, acquisitions, or other business transactions. The exceptions
identified in this paragraph apply to all disclosures under Section H except to the extent that a disclosure is
otherwise prohibited by law.
The Government will provide Contractor with a written notice prior to releasing, in response to a Freedom of
Information Act (FOIA) request, any document submitted by Contractor to Government. During this period,
Contractor shall have the right to notify Government which documents, if any, contain trade secrets of Contractor, or
its collaboration partners (or other information legally withholdable from release under FOIA).
H.2 Publication and Publicity
The contractor shall not release any press releases, or any other publications, which address delivery of product
under this contract, without prior written notice in advance to the Government.
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(a) Unless otherwise specified in this contract, the contractor may publish the results of its work under this contract.
The contractor shall promptly send a copy of each proposed publication which contains delivery, timing or
government sites to the COR for security review prior to publication. The contractor shall also inform the COR
when and how the abstract article or other publication was published, and furnish a copy of the final product.
(b) Neither Contractor nor the Government shall make, or permit any person to make, any public announcement
concerning the existence, subject matter or terms of this Contract, the transactions contemplated by it, or the
relationship between Contractor and the Government hereunder, without the prior written consent of the other,
such consent not to be unreasonably withheld or delayed, except as required by law, any governmental or
regulatory authority (including, without limitation, any relevant securities exchange), any court or other authority
of competent jurisdiction.
(c) Notwithstanding the foregoing, Contractor retains the right, but not the obligation, to prepare and submit
scientific publications and release information to the public about its COVID-19 development program, without
the Government’s consent or involvement, if said publication or release of information contains no information
regarding any Government activity.
(d) Unless authorized in writing by the Contracting Officer, the contractor shall not display any Government logo or
seal including Operating Division or Staff Division logos on any publications.
(e) The contractor shall not reference the products(s) or services(s) awarded under this contract in commercial
advertising, as defined in FAR 31.205-1, in any manner which states or implies DoD approval or endorsement of
the product(s) or service(s) provided.
H.3 Confidentiality of Information
(a) Confidential information, as used in this article, means non-public information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining to an
institution or organization.
(b) The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this
contract specific information and/or categories of information which the Government will furnish to
the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the
Contracting Officer and the Contractor may, by mutual consent, identify such confidential
information from time to time during the performance of the contract. Failure to agree will be settled
pursuant to the contract "Disputes" clause (FAR 52.233-1).
(c) Ifit is established elsewhere in this contract that information to be utilized under this contract, or a
portion thereof, is subject to the Privacy Act, the Contractor and the Government will follow the rules
and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing
regulations and policies, with respect to systems of records determined to be subject to the Privacy
Act.
(d) The Receiving Party shall not directly or indirectly, divulge or reveal to any person or entity any
Confidential Information of another Party without the Disclosing Party’s prior written consent, or use
such Confidential Information except as permitted under this Contract. Confidential Information shall
be subject to the same prohibitions on disclosure as provided for under FAR Part 24.202. Further, any
reproduction of Confidential Information or portions thereof that is disseminated within the
Government or Contractor, shall be shared strictly on a need to know basis for the purposes of this
Contract and is subject to the restrictions of this provision. In addition to the above, Confidential
Information may be subject to the protections of the Trade Secrets Act as well as any other remedies
available under this Contract or the law.
(e)
(f)
(g)
(h)
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Such obligation of confidentiality shall not apply to information which the Receiving Party can
demonstrate through competent evidence: (i) was at the time of disclosure in the public domain; (ii)
has come into the public domain after disclosure through no breach of this contract; (111) was known
to the Receiving Party prior to disclosure thereof by the Disclosing Party; (iv) was lawfully disclosed
to the Receiving Party by a Third Party which was not under an obligation of confidence to the
Disclosing Party with respect thereto; (v) was approved for public release by prior written permission
of the Disclosing Party; or (vi) required by law or regulation to be disclosed, provided, however, that
the Receiving Party has provided written notice to the disclosing party promptly so as to enable such
disclosing party to seek a protective order or otherwise prevent disclosure of such information. For
clarity, Contractor shall have the right to disclose Contractor’s Confidential Information to any third
parties as necessary to perform this contract.
Whenever the Contractor is uncertain with regard to the proper handling of material under the
contract, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this clause, the Contractor shall obtain a written determination from the
Contracting Officer prior to any release, disclosure, dissemination, or publication.
Contracting Officer Determinations will reflect the result of internal coordination with appropriate
program and legal officials.
The provisions of paragraph (H.3.d) of this clause shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
The obligation of the Receiving Party under this Article shall continue for a period of seven (7) years
from conveyance of the Confidential Information.
H.4 Reserved
H.5 Regulatory Compliance
(a)
(b)
The manufacturing described in the Statement of Work will comply with Current Good
Manufacturing Practices (CGMP) regulations at 21 CFR Parts 210 and 211. Production shall occur
using cGMP manufacturing process, fully compliant with 21 CFR Parts 210 and 211, for bulk drug
substance and fill and finished drug product, with a ramp-up capacity that provides doses sufficient to
meet Contractor’s obligations under this Agreement.
Production and distribution shall comply with applicable provisions of the Drug Supply Chain
Security Act (DSCSA), Sections 581-585 of PL 113-54 (Nov 27, 2013), taking into account FDA’s
regular guidance for the COVID-19 public health response, including any waivers or exceptions.
H.6 Public Readiness and Emergency Preparedness (PREP) Act:
In accordance with the Public Readiness and Emergency Preparedness Act (“PREP Act’), Pub. L. No. 109-
148, Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e), as well
as the Secretary of HHS’s Declaration Under the Public Readiness and Emergency Preparedness Act for
Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020),
as amended (together, the “Prep Act Declaration”):
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(a) This Agreement is being entered into for purposes of facilitating the manufacture, testing,
development, distribution, administration, and use of “Covered Countermeasures” for responding to
the COVID-19 public health emergency, in accordance with Section VI of the PREP Act Declaration;
(b) Contractor’s performance of this Agreement falls within the scope of the “Recommended Activities”
for responding to the COVID-19 public health emergency, to the extent it is in accordance with Section
Ill of the PREP Act Declaration; and
(c) Contractor is a “Covered Person” per Section V of the PREP Act Declaration.
Therefore, in accordance with Sections IV and VII of the PREP Act Declaration as well as the PREP Act
(42 U.S.C.§ 247d-6d), the Department of Defense contracting via assisted acquisition on behalf of the
HHS, expressly acknowledges and agrees that the HHS PREP Act Declaration cited above, specifically
its language providing immunity from suit and liability is applicable to this acquisition as long as
Contractor’s activities fall within the terms and conditions of the PREP Act and the PREP Act
Declaration.
The Government may not use, or authorize the use of, any products or materials provided under this
contract, unless such use occurs in the United States (or a U.S. territory where U.S. law applies such as
embassies, military and NATO installations) and is protected from liability under a declaration issued
under the PREP Act, or a successor COVID-19 PREP Act Declaration of equal or greater scope. Any use
where the application of the PREP Act is in question will be discussed with Contractor prior to use and, if
the parties disagree on such use, the dispute will be resolved according to the contract “Disputes Clause”
(FAR 52.233-1).
H.7 Most Favored Nation Clause
(a) If, at any time prior to, or during, the base term and any exercised options of this contract, Contractor
enters into any agreement with a Covered Nation under which the Covered Nation commits to
purchase (i) the same or a lesser volume of Product than the U.S. Government commits to purchase
(ii) at a price lower than the price the U.S. Government is obligated to pay for Product under this
contract, Contractor shall provide notice of such lower price to the U.S. Government within 30 days
of the execution of the Contractor-Covered Nation agreement and the U.S. Government may elect, at
its discretion, to receive the benefit of this provision and purchase the Product at that lower price.
(b) Upon any such election by the U.S. Government, this contract shall be deemed to have been amended
and modified such that, from the date on which the lower priced courses are first supplied or
delivered to the applicable Covered Nation (the “Amended Pricing Effective Date’’), the U.S.
Government will receive that lower price for Product for which Contractor has not invoiced the U.S.
Government following that Amended Pricing Effective Date.
(c) Any price reductions provided hereunder are not intended as an inducement or reward for any
procurement or purchasing decisions by the U.S. Government of any Contractor product.
(d) For purposes of this section, “Covered Nation” shall mean a nation that is a member of the Group of
Seven (Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States) plus
Switzerland and “Product” shall the mean 5-day treatment courses of Contractor’s COVID-19 oral
antiviral treatment (i.e., PF-07321332) that is the subject of this contract.
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(e) The USG shall not be entitled to the price of Product purchased by a Covered Nation for purposes of
donation or resale by the Covered Nation to non-governmental organizations, intergovernmental
organizations, or “lower-income” or “lower middle-income countries” as those terms are defined by
the World Bank as of the date of the effective date of agreement between Contractor and the Covered
Nation.
(f) For clarity, if Contractor enters into an agreement with more than one nation, a multinational
organization, or a multilateral organization, and a Covered Nation receives Product under such an
agreement or benefits from the price under such an agreement, the Parties agree that the relevant
volume for purposes of H.7.(a)(i) shall be the total Product volume specified in such agreement and
not the Product volume any one Covered Nation receives.
H.8 Reserved
H.9 Acceptance, Invoicing, Payment, and Risk of Loss
Contractor will provide Release Documentation to the COR for review. The COR will review and, when
appropriate and in a timely manner and no more than 2 business days after submission, will notify
Contractor of the Government’s acceptance, on a lot-by-lot basis. Upon acceptance by the Government
and delivery to the Contractor designated storage facility, title to accepted treatment courses will pass to
the Government. Contractor will invoice the Government on a monthly basis for accepted treatment
courses, and the Government shall make payment in accordance with FAR 52.212-4(i).
Regardless of where acceptance occurs, risk of loss of, or damage to, supplies shall remain with the
contractor until delivery of Final Drug Product (FDP) to USG’s designated end destination, as set forth in
H.10. In the event of loss of, or damage to, accepted product prior to delivery to USG’s end destination,
the Government shall accept replacement product as its sole remedy. All end destinations shall be located
in the United States, its territories or possessions.
“Release Documentation” shall mean lot documentation limited to sample label, Safety Data Sheet,
Certificate of Compliance and Certificate of Analysis.
H.10 Transportation to Final Destination
During the course of performance under this contract, the Government may require storage of the drug
product before delivery to the end destination. In these circumstances, the Government will accept FDP at
the contractor facility (Origin), as specified in H.9. The contractor however, shall continue to be
responsible for secure delivery of the therapeutic to the USG designated end destination.
H.11 Intellectual Property Rights
Contractor represents that, to its knowledge, the rights held by or granted to the Contractor, including rights in
pending patent applications, if granted, will be sufficient to enable the Contractor to perform its obligations under
the contract. Notwithstanding the foregoing, if the Contractor later determines that additional rights are needed or
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desirable to perform its obligations under this contract, Contractor will make reasonable efforts to obtain any such
rights, including all intellectual property licenses. Nothing in this clause or any other term of this Agreement
constitutes express or implied Government authorization and consent for Contractor or its subcontractor(s) to utilize,
manufacture or practice inventions covered by valid United States or foreign patents to which Contractor or its
subcontractor(s) does not have rights in the performance of work under this Agreement.
H.12 No Government Funding
The awardee represents that it has not received U.S. Government funding for the awardee’s research
and/or development of its oral antiviral compound, PF-07321332, for the potential treatment of SARS-
CoV-2 Coronavirus.
H.13 Termination
The Government may terminate this contract for cause in accordance with FAR 52.212-4 (m). If the
Government contemplates a termination for cause, the contracting officer shall give the contractor written
notice specifying the failure and providing a period of 30 days (or longer period as necessary) in which to
cure the failure. Upon expiration of the 30 days (or longer period), the contracting officer may issue a
notice of termination for default unless it is determined that the failure to perform has been cured.
Notwithstanding FAR 52.212-4(1), the Government will not exercise its unilateral right to Terminate for
Convenience during the performance of work supported by this contract.
Termination for Product Discontinuation. In the event that (a) Contractor notifies the Government that, as a result of
emerging safety or efficacy data, Contractor is ceasing efforts to develop its oral protease inhibitor compound, PF-
07321332, (b) Contractor does not receive an EUA for the use of PF-07321332 to treat COVID-19 by the end of Q1
2022, or (c) Contractor receives U.S. regulatory approval or authorization, but such approval or authorization is
subsequently withdrawn and, after a reasonable amount of time, the parties determine that the authorization will not
be restored or approval will not be granted, the Government may notify Contractor of its intent to terminate this
Contract, and the Parties will agree to effect a no-cost settlement to end performance of this Agreement within thirty
(30) days of such notice. From and after the effective date of any such termination, Contractor shall have no further
obligation to deliver PF-07321332, and the Government shall have no further obligation to accept PF-07321332 for
delivery.
The Government acknowledges that as of the effective date of this contract, Contractor’s compound, PF-
07321332, is in clinical development and remains subject to clinical, technical, manufacturing and
regulatory success, among other risks.
H.14 Buy Back
In the event that the EUA or NDA for PF-07321332 is revoked due to safety or efficacy concerns that
were not apparent at the time of contract award, except for a EUA or NDA revocation related to
decreased efficacy of PF-07321332 on COVID-19 variants, the Contractor, at the Government’s request,
agrees to buy back from the Government all treatment courses accepted by the Government under this
contract that have a remaining shelf life and have yet to be distributed to third parties for administration or
to administration sites. Courses that are bought back under this provision will be destroyed. Contractor
shall notify the contracting officer immediately upon notification of revocation of the EUA. Contractor
shall repurchase the courses within (30) days of the notice at the same price as purchased by the
Government unless otherwise agreed.
H.15 Donation of Excess Product
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A. Inthe event the Government determines that doses of PF-07321332 funded under the contract are no
longer needed by the Government, the Government may donate, either directly or through a non-
governmental organization or intergovernmental organization, remaining doses to any "lower-
income" or "lower middle-income countries", as those terms are defined by the World Bank as of the
date of donation (“Donee Nation”), that: (1) (a) has an active marketing approval in place for use of
PF-07321332 at the time of donation or, (b) if no marketing approval is in place, has an active
regulatory authorization and (2) has entered into an indemnification/limitation of liability agreement
with Contractor that covers donated doses.
B. The Government shall notify Contractor prior to any planned donation to a Donee Nation. Contractor
agrees to work with the Government in good faith to ensure all applicable regulatory submissions,
import/export permits, and other requirements for donation are completed in advance of shipment to
the extent that donation is authorized under Paragraph A above. Nothing in this Paragraph shall
require the Contractor to seek regulatory approval in any particular country.
C. Contractor will be responsible for shipment of PF-07321332 to the receiving Donee Nation; provided,
however, Contractor shall have no obligation to repackage or relabel the courses already purchased
by the USG for delivery to the U.S.market and provided further that Contractor shall only be
responsible for shipment of the courses of PF-07321332 to one reasonable location within the
receiving Donee Nation, or as otherwise agreed between the Parties. Contractor shall be responsible
for the cost of standard shipping; expedited shipping will be paid for by the U.S. Government. The
minimum quantity to be shipped by Contractor is one shipper. Upon execution of this contract, one
shipper contains 100 treatment courses,
D. The parties acknowledge that Article H.6 regarding PREP Act coverage does not apply to the
provision of any doses under this paragraph to a Donee Nation. The USG makes no representations as
to PREP Act coverage thereto.
H.16 Special License Agreement
Pursuant to DFARS 252.227-7015, incorporated into this contract, this Special License Agreement hereby
grants Limited Rights (as defined by DFARS 252.227-7013(a) incorporated herein) including the right to
use, modify or reproduce Technical Data (as defined by DFARS 252.227-7013(a)(15) incorporated
herein) within the Government for non-manufacturing purposes as provided for in DFARS 252.227-
7015(c) in all Technical Data comprising the deliverables identified in contract Attachment [deliverables
table] Data Rights, except the Deliverable identified as A020 (Educational Materials), for which the data
rights are granted as specifically stated therein.
This agreement does not alter any rights that the U.S. Government may have previously obtained under
other agreements with third parties. Section B CLIN 0001 is full compensation to the Contractor for all
of the deliverables and rights granted by this contract inclusive of all contract clauses.
The Contractor shall mark all deliverables referred to above as required under DFARS 252.227-
7013(f)(4). The contractor hereby warrants that it has secured all rights necessary to grant the U.S.
Government the rights as recited above.
H.17 Subject Inventions Not Expected
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The Government acknowledges that it is not funding research, development or chemistry manufacturing and
controls (CMC)/process development under this contract. As such, neither the Contractor nor the Government
expect that conception or reduction to practice of any Subject Inventions will result from performance under this
contract. Accordingly, as between the Contractor and the Government, any and all inventions conceived or first
reduced to practice in the performance of this contract shall be owned by Contractor.
H.18 Limitation of Liability
In addition to the protections afforded under the PREP Act discussed above, the Contractor will not be liable to the
Government for consequential damages resulting from any defect or deficiencies in accepted items. Notwithstanding
the foregoing, in the event Contractor is found liable for any damages under this contract, such damages shall be
limited to the amount of payments Contractor has received from the Government hereunder.
H.19 Excusable Delays
The parties recognize that the global pandemic caused by COVID-19 has had a significant impact on the availability
of certain suppliers and other resources necessary to produce certain pharmaceutical and related products.
Accordingly, notwithstanding any provision in this contract to the contrary, Contractor shall not be liable for default
if nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault
or negligence, as contemplated in FAR 52.212-4(f). For avoidance of doubt, occurrences beyond the reasonable
control of the Contractor and without its fault or negligence also include supply chain disruptions arising from or
related to the COVID-19 pandemic and the availability of materials for performance of this contract.
In the event of an excusable delay caused by a supply chain disruption arising from or related to the COVID-19
pandemic and the availability of materials for performance of this contract, Contractor shall follow the procedures at
FAR 52.212-4(f). The Government acknowledges and agrees that Contractor’s efforts to manufacture and deliver on
the timeline set forth in this contract are aspirational in nature and subject to significant risks and uncertainties.
Accordingly, notwithstanding any provision to the contrary herein, the Contractor will be granted reasonable delay
in performance if it is caused by an occurrence beyond the reasonable control of the Contractor and without its fault
or negligence.
H. 20 EUA Wind Down
EUA Wind-Down. If a NDA is approved during the term of this Contract for PF-07321332, Contractor shall ensure
that any treatment course subsequently provided to the Government under this Contract, after a reasonable amount
of time in which to runoff existing inventory, are appropriately labeled and are otherwise suitable for use in the
United States under the terms of the EUA (before expiration) or the NDA. This plan will be approved by the FDA.
ADDENDA
Inspection and Acceptance Section Clause Addenda
For the purposes of this contract, FAR 52.246-2 and FAR 52.246-16 are superseded in their entirety by H.9
Acceptance, Invoicing, Payment, and Risk of Loss.
Addenda to DFARS 252.204-7003
This contract does not include the acquisition of "government personnel work product" per DFARS 252.204-7003.
DFARS Clause 252.227-7037 does not apply to any of the CDRLs in the Data Deliverables Table. To the extent
there is other technical data furnished under this contract, Pfizer shall comply with DFARS Clause 252.227-7037.
LIST OF ATTACHMENTS & EXHIBITS
Number Transmitted
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List of Addenda Title Date of Pages _b
Exhibit A CDRLs/Deliverable Table 28 OCT 2021 21 EMAIL
Attachment 0001 Pfizer Subcontracting Plan 1 JUN 2021 13 EMAIL
EXHIBIT A
EXEMPT FROM DISCLOSURE UNDER FOIA EXEMPTION FOUR
EXHIBIT A, ANTIVIRAL DELIVERABLES TABLE
Post Award
Teleconference
Every 2 Weeks
Program Progress
Meeting (PPM)
Daily check in with
project staff for
COVID-19
Contract
A003
The contractor shall complete an
initial teleconference after contract
award
1. Outline activities for the next
30 days
The Contractor shall participate in
teleconferences every 2 weeks after
contract award with BARDA to
discuss the performance on the
contract. Contractor shall provide a
mutually agreed upon standard
status report and progress update
covering:
e Clinical Development (e.g.
enrollment numbers and high-
level results from the proof-of-
concept, interim and full analyses)
Key FDA engagements (e.g. Type
A.B.C, meetings, approvals,
major notifications, inspections,
findings 483s, EIR etc.).
Contractor retains right to redact
from any FDA communications
information unrelated to the
Product
Manufacturing / Distribution
(schedule adherence, delivery
updates, USG inventory position,
audits)
e Contract deliverables updates
Contractor shall participate in a
daily check-in update if necessary
with the Project Managers and
additional project staff as needed
e Within one week of contract award
eContractor shall provide agenda and
establish a teleconference number at
least 3 business days in advance of
the teleconference unless notified
that BARDA will supply one
eCOR edits/approves and instructs
contractor to distribute agenda prior
to meeting by at least 2 business
days
eContractor provides meeting
minutes to COR within 5 business
days after the meeting
eCOR reviews, comments and
approves minutes within 10
business days of receipt
eFirst meeting within a month of
contract award, pending
concurrence by the contracting
officer
eContractor shall provide itinerary
and additions to standing agenda at
least 2 business days in advance
COR edits/approves and instructs
contractor to distribute agenda 1
day in advance
eContractor provides meeting
minutes and all standard agreed
update slides and data presented to
COR within 5 business days after
the meeting
COR reviews, comments, and
approves minutes within 5 business
days of receipt
e Contractor shall notify BARDA of
upcoming FDA meetings (Type
A,B,C) at the every 2 weeks
meeting
eThe Contractor shall forward FDA-
issued final minutes of any meeting
with the FDA to BARDA within 5
calendar days of receipt
eNo agenda will be required for the
meeting
eNo meeting minutes are required
Limited
' As used in this table, Limited Rights has the meaning defined by DFARS 252.227-7013(a).
Monthly & Annual
Technical Progress
Reports/Annual
Meeting
Draft and Final
Deliverables
Progress Report
(via teleconference or email).
Potential triggers for the check-in
include but are not limited to
regulatory status changes,
manufacturing and or/distribution
problems that will affect delivery
Daily check-ins may occur on
weekdays, excluding federal
holidays. Upon agreement of both
parties, check-ins may also occur on
weekends and on federal holidays,
provided at least 24 hours’ notice.
A consolidated submission of all
slides and data presented at the
biweekly telecoms will serve as the
monthly report. The report only
consists of a summary of quantity of
product delivered, when and
location of the delivery.
A Draft and Final Deliverables
Progress Report containing a
summation of the deliverables
performed over the entire Contract.
This report shall be in sufficient
detail to describe the progress
achieved and completion of agreed
upon deliverables. Report should
contain original schedule and
attained schedule during the
Contract. Descriptions and rationale
for SOW items that were not
completed as planned should be
provided. The draft report shall be
duly marked as Draft.” The final
report should be submitted and
marked as FINAL. This report
should be a comprehensive
summary of the quantity of product
delivered, when it was delivered and
where.
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eContractor will provide bulleted
email updates following any call or
in lieu of a call by 2PM for that day
Monthly Reports shall be submitted
on the 20® day of the month
covering the preceding month:
Annual Reports submitted on the
30% calendar day of the month after
each contract anniversary. Monthly
progress reports are not required
for the months when the Annual
Report(s) are due, and
Monthly/Annual
Report(s) are not due during a
month when the Final Report (final
version, not draft) is due (see
CDRL A009). The COR and CO
will review the monthly reports
with the Contractor and provide
feedback within 10 business days
of receipt.
eContractor shall provide FINAL
versions of reports within 10
business days after receiving
BARDA comments/edits
eThe Draft Deliverables/Progress
Report shall be submitted 75
calendar days before the end of the
PoP and the Final Deliverables
Progress Report on or before the
end of the PoP
eCOR will provide feedback on
draft report within 15 calendar days
of receipt, which the Contractor
shall consider incorporating into
the Final Report
Product Source The Contractor shall update Product | Contractor will update Product Limited
A006 Material and Source Material and Contractor Source Material Report
Supply Chain and
Distribution
Tracking
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Locations Report submitted during Within 30 days of
Project Coordination Team (PCT) substantive changes are
meetings regarding critical project made to sources and/or
materials that are sourced from a materials
location other than the United Contractor will update the
States, sources, and manufacturing treatment course tracking
sites, including but not limited to: projections every two weeks
physical locations of sources of raw Updates will be provided at each
and processed material by type of PPM.
material; location and nature of e Contractor shall provide update
work performed at manufacturing within 48 hours if treatment course
sites delivery schedule is impacted by
more than 15% from agreed
The Contractor will provide baseline schedule.
completed manufacturing reports eThe Government may request a
and manufacturing treatment course | daily check in meeting to discuss
tracking projections/actuals concerns and recommend corrective
This deliverable only applies to actions
material manufactured for this
Contract and which the Government
has agreed to purchase.
The contractor shall submit detailed
data regarding locations where work
will be performed under this
contract, including addresses, an
overall manufacturing point of
contact, and work performed per
location, to include sub-contractors
BARDA and MCM Manufacturers Provide the following information in
play an important role in the order to coordinate the movement
distribution of therapeutics to the and delivery of antiviral product
American people under a nationwide | from manufacturing locations to a
response. BARDA will work with single distributor and pharmacies
the manufacturer to monitor e Provide a Point of Contact
anticipated delivery schedule using a information (name, title, phone,
tracking template subject to email) for manufacturing /
Contractor’s approval. Contractor supply chain matters
will relay final drug product Provide therapeutic labeling,
information as it is released to the packaging and distribution
BARDA/ASPR. This information information within 12 hours of
will be returned to BARDA, the it becoming available. At a
contractor and the distributor. The minimum, include the
distributor will use that information following, and as applicable:
to ship therapeutics to pharmacies. Primary Packaging
Information
e Number of doses per
primary pack
e Unit of Sale (carton, box,
package, other)
© Quantity per Unit of Sale
e National Drug Code
(NDC) or NDC-like code
under EUA
e Unit of Sale dimensions
(H,W, L)
e Unit of Sale weight
This plan shall be developed in
accordance with the Statement of
Work and in collaboration with the
Government and will describe the
process to distribute EUA-or NDA-
approved product to pharmacies,
necessary to meet the Government’s
need for administration. The plan
shall comply with applicable
provisions of the Drug Supply Chain
Security Act (DSCSA), Sections
581-585 of PL
113-54 (Nov 27, 2013), taking
into account FDA’s regular
guidance for the COVID-19
public health response.
Contractor’s PF-07321332 is
exempt in the US from
serialization at this time due to
the ongoing Public Health
Emergency (PHE) Contractor
continues to build/invest in
serialization readiness on our
packaging lines for PF-
07321332. Contractor plans to
begin serializing PF-07321332
at the unit of sale once NDA
approved and the product is no
longer included in the PHE.
A008 Distribution Plan
Distribution M This document is an understanding Initial MOU and any amendments Limited
A009 of Undertandine | between ASPR, contractor, and the | will be delivered electronically to
. the COR and CO within 45 days of
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e Intermediate Package
e Intermediate Package
dimensions
e Intermediate Package
weight
© Quantity Unit of Sale per
pallet
e Storage Requirements
e Stability Information
e Obtain concurrence on planned
shipment protocols prior to
transport
Include the following DSCSA
data elements, TI, TH and TS in
packing lists.
Include the contract number on
the packing list for all shipments
Include a copy of the MSDS
(with QR code) in the packing list
envelope with each shipment.
Send electronic/scanned copies of
all bulk shipment related
documents to the COR for three-
way matching on the day
shipment occurs.
Initial Plan and any amendments
will be delivered electronically to
the COR and CO within 60 days of
award unless otherwise agreed by
the Parties. The Government shall
approve the Distribution Plan before
distribution can commence.
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sal
Dates
each party to work together. parties.
This plan shall describe the
manufacturing process for the
product in a level of detail and
format that is mutually acceptable to
the Government and Contractor to
ensure conformity with
§501(a)(2)(B) of the Food, Drug,
and Cosmetics Act (FD&C Act,
Title 21 United States Code (USC)
§351 (a)(2)(B)), regarding good
manufacturing practices (GMP)),
but is not limited to planned or
completed drug substance studies;
list of excipients and information to
support the safety of excipients that, | Plan will be delivered electronically
when appropriate, shall be cross- within 30 days of contract award to
referenced; drug product and the CO and COR
formulation development summary
from initial concept through final
design; physicochemical and
biological properties: manufacturing
process development and validation
program documents; container
closure system documents
microbiological attributes
documents and plans; compatibility
documents (e.g., precipitation);
assay development and validation,
stability plan: and any associated
risks.
Manufacturing
Development Plan
This shall describe the Quality
Management Plan for the product in
a level of detail and format that is
mutually acceptable to the
Government and Contractor. Plan
may include but is not limited to the
manufacturing quality policy and
objectives, management review,
competencies and training, process Plan will be delivered
Quality document control, feedback, electronically within 30 days of
Management Plan | evaluation, corrective action and contract award to the CO and
preventive action, process COR.
improvement, measurement, and
data analysis processes. The
framework is normally divided into
infrastructure, senior management
responsibility, resource
management, lifecycle management,
and quality management system
evaluation
Release Contractor will deliver Certificate of
Documentation for | Analysis and Certificate of Documentation shall be provided at
treatment courses to | Compliance for doses to be least 14 days prior to delivery
be Delivered delivered
Security Plan
Supply Chain
Resiliency Plan
No CUI will be exchanged between
the parties in relation to this
contract.
Develop a comprehensive security
program that provides overall
protection of personnel,
information, data, and facilities
associated with fulfilling the
obligations under this contract.
The Government acknowledges
that this program will reflect
Contractor’s established
security procedures in place
with respect to its facilities and
information security, which are
at least as protective as would
be customary for a global
company. Contractor will use
commercially reasonable
efforts to implement any
further procedures/precautions
reasonably requested by the
Government with respect to
Statement of Work, at
Contractor’s sole discretion and
as long as such implementation
would not adversely impact
Contractor’s ordinary operation
of its facilities and systems in
connection with its other
business and products.
This plan shall establish security
practices and procedures that
demonstrate how the Awardee will
meet and adhere to the security
program, and-shall be delivered to
the Government within thirty (30)
calendar days of award or as
otherwise agreed by the parties. The
Contractor shall also use
commercially reasonable efforts to
ensure all subcontractors.
consultants, researchers, etc.
performing work on behalf of this
effort, comply with all Government
security requirements and
Contractor’s security plans.
A comprehensive Supply Chain
Resiliency Program,
or Contractor Equivalent.
that provides identification and
reporting of critical components
associated with the secure supply of
drug substance, drug product, and
work-in-process through to finished
goods.
A critical component is defined as
any material that is essential to the
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The Government will review in
detail and submit comments
within ten (10) business days to
the CO and COR to be
forwarded to the Contractor.
The-Contractor shall review the
Draft Security Plan comments,
and, submit a Final Security
Plan to the U.S. Government
within thirty (30) calendar days
after receipt of the comments.
The Security Plan shall include
a timeline for compliance of all
the required security measures
reasonably requested by the
Government.
Upon completion of initiating all
security measures, the Contractor
shall-supply to the Contracting
Officer a letter certifying
compliance to the elements outlined
in the Final Security Plan.
Delivery of plan is within 60
calendar days of award
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product or the manufacturing
process associated with that product.
Included in the definition are
consumables and disposables
associated with manufacturing. NOT
included in the definition are facility
and capital equipment.
Consideration of critical
components includes the evaluation
and potential impact of raw
materials, excipients, active
ingredients, substances, pieces,
parts, software, firmware, labeling,
assembly, testing, analytical and
environmental componentry,
reagents, or utility materials which
are used in the manufacturing of a
drug, cell banks, seed stocks,
devices and key processing
components and equipment.
A clear example of a critical
component is one where a sole
supplier is utilized.
The contractor shall identify key
equipment suppliers, their locations,
local resources, and the associated
control processes at the time of
award. This document shall address
planning and scheduling for active
pharmaceutical ingredients,
upstream, downstream, component
assembly, finished drug product and
delivery events as necessary for the
delivery of product.
a) Communication for these
requirements shall be updated as
part of an annual review, or as
necessary, as part of regular
contractual communications.
b) For finished goods, the
inspection, labeling, packaging, and
associated machinery shall be
addressed taking into account
capacity capabilities.
c) The focus on the aspects of
resiliency shall be on critical
components and aspects of
complying with the Agreement
delivery schedule. Delivery methods
shall be addressed, inclusive of
items that are foreign-sourced, both
high and low volume, which would
significantly affect throughput and
adherence to the contractually
agreed deliveries.
The Contractor shall articulate in the
plan, the methodology for inventory
control, producti
AQIS BARDA Audit
planning, scheduling processes and
ordering mechanisms, as part of
those agreed deliveries.
a) Production rates and lead times
shall be understood and
communicated to the Contracting
Officer or the Contracting Officer's
Representative as necessary.
b) Production throughput critical
constraints should be well
understood by activity and by
design, and communicated to
contractual personnel. As necessary,
communication should focus on
identification, exploitation,
elevation, and secondary constraints
of throughput, as appropriate.
Reports for critical items should
include the following information:
I. Critical Material
II. Vendor
If. Supplier, Manufacturing /
Distribution Location
IV. Supplier Lead Time
V. Shelf Life
VI. Transportation / Shipping
restrictions
The Contracting Officer and the
Contracting Officer’s Representative
reserve the right to request un-
redacted copies of technical
documents provided in response to
this subsection, during the period of
performance, for distribution within
the Government.
Documents shall be provided within
ten (10) days after CO issues the
request. The contractor may arrange
for additional time if deemed
necessary, and agreed to by the CO.
The Government will have Limited
Rights in any documents provided
under this subsection.
Contractor shall accommodate
for cause site visits related to
manufacturing of US supply by
BARDA upon 30 days written
notice and during normal
business hours.
If BARDA, the Contractor, or other
parties identifies any issues during
an audit, the Contractor shall capture
the issues, identify potential
solutions, and provide a report to
BARDA
This deliverable only applies to
material manufactured for this
W58P0522C0001
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elf issues are identified during the
audit, Contractor shall submit a
report to BARDA detailing the
finding and corrective action(s)
within 20 business days of the audit
eCOR and CO will review the report
and provide a response to the
Contractor with 10 business days
Once corrective action is completed,
the Contractor will provide a final
report to BARDA
Master Delivery
Schedule and
Delivery Deviation
Notification
FDA
Correspondence and
Submissions
BARDA reserves the right to
participate in for cause QA audits by
Contractor related to manufacturing
performed by the sub-contractors if
BARDA participation is acceptable
to the Contractor and the
subcontractor. Upon completion of
the audit/site visit the Contractor
shall provide a report capturing the
findings, results and next steps in
proceeding with the subcontractor.
If action is requested of the
subcontractor, detailed concerns for
addressing areas of non-
conformance to FDA regulations for
GMP guidelines, as identified in the
audit report, must be provided to
BARDA. The Contractor shall
provide responses from the
subcontractors to address these
concerns and plans for corrective
action
The contractor shall provide a
Master Delivery Schedule including
a list of critical milestones that must
be met to ensure on time
delivery. The Master Delivery
Schedule must provide baselines for
achieving critical milestones. The
Master Delivery Schedule may be
limited to those milestones
associated with delivery of the
product. Contractor may provide
pre-existing documentation of
critical milestones.
Contractor shall use diligent efforts
to notify the Government within 48
hours of any event, risk, formal or
informal FDA communication, or
other issue that would be reasonably
expected to materially change the
anticipated delivery schedule by one
week or more.
FDA Interactions and Inspections
Documentation. Contractor shall
provide the Government within 72
hours of receipt any FDA Form 483,
Establishment Inspection Report
(EIR). regulatory authorization or
approval-related letter and/or
warning or untitled letter that is
reasonably likely to materially
impede production or the ability to
ly deadlines under the
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*Contractor shall notify CO and
COR a minimum of 10 business
days in advance of upcoming,
audits/site visits of subcontractors
*Contractor shall provide the COR
and CO with the Executive
Summary and subsequent response
corrective/actions if applicable
within 10 business days of
completion.
COR and CO will review the report
and provide a response to the
Contractor with 10 business days
eThe Master Delivery Schedule is
due within 30 business days of
contract award
eThe Government will request
revisions within 10 business days,
at which point the schedule
baseline for the period of
performance will be set
eIn the event of Delivery Schedule
slippage, Contractor shall provide
high level details to return to
original delivery schedule, or as
close to agreed schedule as
possible within 5 days of
establishing slippage will be
realized
eAn Incident Report will be
provided within 5 days for
incidents that present liability to the
project
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contract, including status of
Emergency Use Authorization
and/or NDA approval
Each party shall ensure that the
other party, (the CO, in the case
of Government), has received and
approved release directly related
to this contract not less than 5
business days prior to the issuance
of the press release unless agreed to
Each party agrees to accurately and | by the COR.
A019 Press Releases factually represent the work e If corrective action is required, the
conducted under this contract in all Contractor agrees to accurately
press releases and factually represent the work
conducted under this contract in
all press releases
Any final press releases shall be
submitted to BARDA no later than
one (1) calendar day prior to its
release
Contractor shall provide a digital The Government
copy of any Materials within five __| has rights to use,
(5) business days of their date of reproduce, display,
first use during the Post- release or disclose
Authorization Period. final, unmodified,
FDA-approved
“Materials” are publicly- educational
disseminated communications materials and to
intended to help inform either have or authorize
HCPs or consumers on the others to do so.
availability and appropriate use
of the product, including
communication of authorized
labeling. For the avoidance of
doubt, “Materials” do not include
unbranded disease awareness
infomercials, websites, etc., subject er = a
a gE eR related scientific-exchange that is
otherwise exempt from FDA
review. :
regulation.
Contractor will develop learning
material to assist in administration
and increase appropriate uptake of
Educational their drug to the public including but
Materials not limited to pamphlets,
“Post-Authorization Period”
means the period of time
following the receipt of an
authorization from the FDA
under an EUA and prior to
receipt of an approval of an NDA
from the FDA, or until such time
the Agreement expires or is
terminated if such date is earlier
than the receipt of NDA approval
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TV News
Understanding
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